Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
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Purpose
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma |
Drug: sorafenib tosylate Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas |
- Objective response rate (complete and partial response) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The Kaplan-Meier product-limit method will be used in analysis of survival time.
- Time to disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.
| Enrollment: | 33 |
| Study Start Date: | October 2005 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
|
Drug: sorafenib tosylate
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib.
SECONDARY OBJECTIVES:
I. Determine progression-free and overall survival of patients treated with this drug.
II. Determine response duration in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed aggressive* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:
- Mantle cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Diffuse large B-cell lymphoma
- Anaplastic large cell lymphoma (T-cell or null-cell type)
- Recurrent disease
- Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP [with or without rituximab] or R-EPOCH)
Chemosensitive disease at the time of relapse
- Patients who responded with a complete or partial remission that lasted at least 8 weeks after their last chemotherapy regimen are considered chemosensitive
- Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest transverse diameter on CT scan
- Ineligible for, refused, or relapsed after stem cell transplant (for patients with non-mantle cell lymphoma)
- No known brain metastases, including meningeal involvement
- ECOG performance status (PS) 0-2
- Karnofsky PS 60-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Fertile patients must use effective contraception
- Not pregnant or nursing
- Negative pregnancy test
- No uncontrolled illness
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
- No known positive HIV serology
- No inflammatory bowel disease
- No swallowing dysfunction that would prevent ingestion of pills
- No hemorrhagic diathesis
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension
- No psychiatric or social situation that would limit compliance with study requirements
- No poorly controlled medical condition that would seriously complicate compliance with this study
- Patients with inflammatory or exfoliative skin disease are excluded (regardless of the extent of the involvement) unless the skin condition is lymphoma related
- See Disease Characteristics
- Previous treatment-related toxic effects should be resolved to grade 1 or better
No chemotherapy or radiation therapy within the past 4 weeks
- 6 weeks for nitrosoureas or mitomycin C
- No prior antibody therapy for at least 3 months
- Prior radiation for localized disease or total body irradiation as part of a conditioning regimen prior to stem cell transplant allowed
- Prior radio-immunotherapy allowed
No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices are acceptable provided that the requirements for PT, INR, and PTT are met
- No concurrent use of another investigational agent
- No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
- No other concurrent anticancer therapy
Contacts and Locations| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201-1595 | |
| Principal Investigator: | Meyer Heyman | University of Maryland Greenebaum Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00278382 History of Changes |
| Other Study ID Numbers: | NCI-2012-02682, GCC0508, CDR0000456442 |
| Study First Received: | January 16, 2006 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Lymphoma, T-Cell Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013